MAUDE Adverse Event Report: ORTHALIGN, INC. LANTERN SURGICAL ASSISTANT; SURGICAL NAVIGATION SYSTEM

Model Number	406000-02
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time the device is not expected to be returned to orthaligg for investigation.Orthalign was able to confirm that the expireation date for the reported navigation unit is (b)(6) 2024, which means that it was expired on the incident date (b)(6) 2024.For this reason, the complaint is confimed and the root cause is deteremined to be user error, as the expireation is clearly visible on the lantern kit box label.Use of device past expiration date is a known potential issue addressed in orthalign's risk documentation, as sterility may be compromisted due to aging effects outside of the expiration date.In this case, no patient harm was reported.This report is being filed out of an abundance of caution and with an understanding of the patient harm that could be caused by use of a device past the expiration date.Orthalign will continute to monitor the issue and take action when complaint limits are reached.No futher action required at this time.
Event or Problem Description
An expired unit was unknowingly used in a procedure.

• Brand Name: LANTERN SURGICAL ASSISTANT
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology; irvine, CA 92618
• MDR Report Key: 20279236
• Report Number: 3007521480-2024-00013
• Device Sequence Number: 18137456
• Product Code: OLO
• UDI-Device Identifier: 00810832031567
• UDI-Public: 00810832031567
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K200892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 406000-02
• Device Catalogue Number: 406000-02
• Device Lot Number: 2305110LS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown